An interventional study of Breast-conserving plastic surgery and Traditional breast surgery in Breast-conserving Plastic Surgery and Granulomatous Mastitis, sponsored by Hubei Cancer Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Hubei Cancer Hospital · Not applicable, Interventional, and Treatment
The objective of this study was to prospectively investigate the effects of different surgical approaches on the recurrence rate and aesthetic outcome of patients with granulomatous mastitis. The patients were divided into traditional surgery group and plastic surgery group.
Granulomatous mastitis is a rare benign inflammatory breast disease first described by Kessler and Wollock in 1972. It resembles inflammatory breast cancer disease in imaging and mainly affects women of childbearing age. Treatment methods include steroid therapy, antibiotics and surgical treatment. However, due to the adverse reactions of drug treatment and the high recurrence rate after traditional surgery, there is no definitive preferred treatment form at present, and most clinicians are still in the stage of empirical treatment.
Breast-conserving plastic surgery has been widely used by surgeons because it can remove a larger range of breast cancer, so it has higher safety and aesthetics compared with traditional breast conserving surgery. So, if patients with mastitis are treated surgically, will they also benefit from breast-conserving surgery? At present, the commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on. Therefore, this study prospectively grouped mastitis patients who selected surgery, and divided them into traditional surgery group and plastic breast-conserving surgery group. The postoperative recurrence, adverse reactions, aesthetics and satisfaction of the two groups were compared.
It is hoped that this study will bring a new research direction for the surgical treatment of mastitis and provide a clearer guiding significance for clinical decision-making.
22 studies on the registry are indexed under Granulomatous Mastitis; 7 are open to participants now.
This study's planned enrollment of 240 is above the median of 61 across 12 interventional studies indexed under Granulomatous Mastitis.
Browse Granulomatous Mastitis studies →Hubei Cancer Hospital is the lead sponsor of 25 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Only the subjects who meet all the following criteria may be included in this study:
Exclusion Criteria:
The subjects who meet any of the following criteria shall not be included in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Breast-conserving plastic surgery
Procedure: Breast-conserving plastic surgery
Traditional breast surgery
Procedure: Traditional breast surgery
The commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on.
Traditional breast surgery
Recurrence rate
The recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.
Time frame: 2, 3, 5 year
Aesthetics scores
The patients' satisfaction and quality of life after surgery were evaluated by BREAST Q questionnaire. The full score is 100, with higher scores indicating higher patient satisfaction and quality of life. Occurring rate of complications including the occurring rate of infection, hemorrhage, time in hospital in each group were recorded in patients' medical record.
Time frame: 2, 3, 5 year
Plan to share: No — Patient information was protected according to the privacy requirements of our unit.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hubei Cancer Hospital